Toxicological risk assessment – ISO 10993-17 (2023)
Toxicological risk assessment – ISO 10993-17 (2023) Questions? Want to know more about our services? Call, mail, or send us a message. +32 493 10 65 08 info@agirad.com Contact us Other news News overview ISO 10993-17:2023 toxicological risk assessment for medical devices: key requirements and practical guidance ISO 10993-17:2023 toxicological risk assessment provides a systematic […]
ICH Q3E Guideline: Extractables & Leachables
The draft ICH Q3E Guideline establishes a harmonized, risk-based framework for managing extractables and leachables (E&L) throughout the lifecycle of drug products. Covering study design, toxicological qualification, acceptable exposure limits, and lifecycle monitoring, Q3E provides manufacturers with a consistent approach to assessing E&L risks while supporting patient safety and regulatory compliance.